A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma.

Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Hydroxyitraconazole; Itraconazole; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

You may be eligible for this study if you:

• Are 18 years of age or older.

• Have been diagnosed with aspergilloma within the last month.

• Have (or have a history of) at least one of the following:

1. positive test for Aspergillus species.

2. presence of antibodies to Aspergillus.

• Are willing to participate in the study for 2 full years.

• Are female and not pregnant.

• Are not breast-feeding.

• Agree to use barrier methods of birth control / contraception during the study and for 30 days after.

Exclusion Criteria:

You will not be eligible for this study if you:

• Have a history of allergy to triazole or imidazole drugs.

• Are unable to take oral medication.

• Are not expected to live for more than a month.

• Have had a lung biopsy indicating Aspergillus infection.

• Have had radiation therapy within the last 6 months.

• Require treatment with certain medications.

• Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.

• Received chemotherapy within the last 6 months.